FDA places a partial hold on all venetoclax clinical trials for multiple myeloma (MM) patients

The U.S. Food and Drug Administration (FDA) put the partial hold on all MM trials when they did a pre-planned look at the data and found double the death risk in the venetoclax arm.

Here is some of the press release from AbbVie:

…the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax (VENCLEXTA®/VENCLYXTO®) for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial. As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician.

This action does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML), and is limited to investigational clinical trials in multiple myeloma. AbbVie remains confident in the benefit/risk profile of venetoclax in those approved indications.

Here is a link to AbbVie’s full press release: Venetoclax Press Release

Dr. Pagel from our medical advisory board had this comment;

The Venetoclax results in these very difficult Multiple Myeloma patients should be viewed with some degree of caution and understanding about the myeloma patient population and their unique clinical profiles.  The patients were heavily previously treated myeloma patients who were at increased risk for therapy associated complications, and in particular an increased risk for infections due to many factors including high doses of the steroid, dexamethasone.  Venetoclax has not been shown to lead to increased risk of infections for those with immunocompetent CLL or other lymphomas, where steroids are not commonly utilized in high-doses.

This is obviously a serious concern that needs to fully probed and analyzed. We need more information and we will get it, but in the meantime the recommendation for all CLL and AML patients is to not stop taking their venetoclax.

If you have concerns or questions, then do contact your treating doctor or AbbVie at 1-800-633-9110.

The CLL Society will keep you informed as we learn more.